Tag: Regulation

Silver Spring, MD, USA - June 25, 2022: The U.S. Department of Health and Human Services (HHS), U.S. Public Health Service (USPHS) and FDA logos are seen at the FDA headquarters, the White Oak Campus.

FDA Solicits Feedback on the Use of AI and Machine Learning in Drug Development

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By Matthew Chun

The U.S. Food and Drug Administration (FDA), in fulfilling its task of ensuring that drugs are safe and effective, has recently turned its attention to the growing use of artificial intelligence (AI) and machine learning (ML) in drug development. On May 10, FDA published a discussion paper on this topic and requested feedback “to enhance mutual learning and to establish a dialogue with FDA stakeholders” and to “help inform the regulatory landscape in this area.” In this blog post, I will summarize the main themes of the discussion paper, highlighting areas where FDA seems particularly concerned, and detailing how interested parties can engage with the agency on these issues.

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Supreme Court of the United States.

The Federal Judiciary Is Broken — But Not for the Reason You Think

Jennifer S. Bard Leave a comment

By Jennifer Bard

Recent events, including the discovery that Justice Thomas has been accepting luxury vacations from and selling real estate to a billionaire, and the Fifth Circuit’s finding in Alliance for Hippocratic Medicine v. FDA that federal courts have the power to modify the conditions under which the FDA can approve a drug, may seem separate. But they’re not. Both involve a threat to our constitutional government and both highlight the need to shield all federal decision makers from entities with billions at stake and a fiduciary interest in increasing the value of their company for the benefit of shareholders. And while issues of influence affecting Supreme Court Justices attract the most attention, the factors that make Justices targets extend across the entire federal judiciary.

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Supreme Court of the United States.

The Bind We’re in — And How the Supreme Court Put Us There

Jennifer S. Bard Leave a comment

By Jennifer Bard

As the COVID-19 pandemic rages into its third year of global death and destruction, the Supreme Court of the United States has effectively thwarted every measure by federal or state government to implement the public health tools that for hundreds of years have been used to stop the spread of contagious disease. They have done so by operationalizing what were previously fringe and relatively harmless academic views in ways that extend their powers beyond any previous boundaries. These include, but are not limited to, extending the protection for religious exercise past any previously imagined, and limiting Congressional authority to respond to emergencies by imposing impossible standards of specificity on its delegation of authority to the agencies which it creates, funds, and directly oversees.

In so doing, the Court has not only undermined the health of the nation, and pushed millions of people into unnecessary long-term disability, which our fragmented health care and social security system is unequipped to handle. It has also threatened our national security by infecting what is already more than half of the children in the country with a virus that has the potential to damage every organ in their bodies, from heart to brain.

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College football on grass field in afternoon sunlight

There’s More Than Rules in Regulating Concussions

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By Jack Becker

The football world has used a variety of methods to make the sport safer: Compare modern football to football a century ago, when at least 18 people died playing the game in 1905 alone and Teddy Roosevelt had to intervene. In recent years, concussions and brain trauma have become football’s scarlet letter. While leagues have already made changes to prevent brain injuries, there’s more to be done.

This post considers the application of Lawrence Lessig’s New Chicago School approach to regulation to the prevention of concussions (and other types of brain damage generalized under the word “concussions” for simplicity) in football.

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Field hospital in NY during COVID-19 pandemic.

Systemic Failures Need Systemic Solutions: COVID-19 and Macromedical Regulation

The Petrie-Flom Center Staff Leave a comment

By Barak D. Richman and Steven L. Schwarcz

Among the many failures to mitigate the harm from COVID-19 in the U.S. has been the failure to meet surging demand for inpatient care. Hospital bed shortages, overwhelmed intensive care nurses, and scarcities of needed medical equipment have been embarrassing but constant features of the American health care landscape. A nation that spends nearly one out of every six dollars on health care should get much, much more for its money.

Though there is much blame to go around — and many insightful commentators have already allocated culpability — we observe that a significant regulatory deficiency has contributed to the nation’s failure to meet population health needs. This is the failure to regulate our hospitals holistically, as part of a comprehensive health care system.

Existing health care regulation focuses almost exclusively on regulating individual components of the health care industry. This existing regulation lacks the capacity to address how those components work together as a system — a system in which deficiencies in one component adversely impact the performance of the other components. We should not view hospitals as individual providers that treat individual patients. Instead, they are part of a larger safety net that needs to expand capacity when emergencies arise. Today’s pandemic destabilized hospital care because hospitals were neither coordinated nor managed systemically in order to meet population demands.

In Macromedical Regulation, 82 Ohio State Law Journal 727 (2021), we address the nation’s systemic failure to contain an infectious contagion, and we offer solutions by deriving lessons from the 2008 financial contagion. We contend that health care regulation must also include what we call “macromedical” regulation: regulation that focuses on protecting the stability of the health care sector as a system of interconnected parts.

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Person filling syringe from vial.

The Beginning of the End of Federalism

Jennifer S. Bard Leave a comment

By Jennifer Bard

Friday’s emergency hearing by the Supreme Court regarding the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate was extraordinary both in that it happened at all and what took place.

The hearing came in a response to a petition by a coalition of states and the National Federation of Independent Business (NFIB) to halt an Emergency Temporary Standard (ETS) issued by OSHA mandating that all employers with over 100 employees “establish minimum vaccination standards” including “vaccination verification, face covering, and testing requirements.”

That the Court heard the case on an emergency basis signaled their concern that OSHA, in issuing the ETS, was overreaching its authority, as they ruled the Centers for Disease Control and Prevention had done in issuing an eviction moratorium.

But what made the colloquies particularly unsettling is that the ETS was carefully crafted to be, as Professors Larry Gostin and Dorit Rubinstein Reiss explain lucidly, well within contemporary standards for an exercise of federal power affecting a health matter usually within the jurisdiction of a state. It applies only to employers already obligated to follow OSHA workplace standards and fell far short of a vaccine mandate. Moreover, however severe the risk of COVID when this was drafted six months ago, the risk from the Omicron variant is many times greater.

Yet the sympathetic ear given by the majority of the Justices to the arguments made by the lawyers seeking a stay made it possible to wonder if the whole thing was happening in either one of DC or the MCU’s multiverse. This is because the questioning, directly and by implication, calls into doubt what past Courts have identified as the framework of federalism — a nickname for the Constitution’s balancing of a strong federal government against the rights of individual states. We cannot know the extent to which the Justices will adopt any of the arguments offered them for limiting federal agency power, but from this hearing we can anticipate substantial strengthening of an individual state’s ability to resist federal regulation.

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U.S. Supreme Court

Major Questions about Vaccine Mandates, the Supreme Court, and the Major Questions Doctrine

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By Wendy Parmet and Dorit Reiss

This Friday, the Supreme Court will hear arguments about two federal vaccine mandates: the Centers for Medicare and Medicaid Services’ (CMS) mandate for health care workers, and the Occupational Safety and Health Administration’s (OSHA) vaccine-or-test mandate for employers with over 100 workers. In each case, a key question will be whether the Court should apply the so-called “major questions doctrine.” The Court’s adoption of this approach in the mandate cases would not only remove an important tool for combating the pandemic; it also would severely limit the federal government’s capacity to address many other health threats, while expanding the Court’s ability to substitute its judgment for Congress’.

Although not fully defined or delineated, the major questions doctrine bars administrative agencies from using broad grants of statutory authorities in new and “major” ways. A type of clear statement rule, it requires courts to presume that in the absence of specific Congressional authorization, agencies lack the power to issue new regulations that could be seen as “major.”

In theory, the rule allows courts to avoid federalism and separation of powers concerns. In practice, it empowers courts to resurrect long-discarded approaches to federalism and separation of powers without saying so. It also enables courts to disregard explicit grants of statutory authority (so much for textualism!).

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Phone with social media icons - instagram, facebook, and twitter.

Regulating Out of the Social Media Health Crisis

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By Bailey Kennedy

If something changes the pathways in our brains and damages our health — and if it does so to Americans on a vast scale — it should be regulated as a threat to public health.

It’s time for our regulators to acknowledge that social media fits this description.

Social media poses an active health threat to many of its users, in a way that is akin to other regulated substances: it has been tied to a variety of harmful health outcomes, including depression. It has also become increasingly clear that social media can be addictive.

Even if it is a behavioral rather than a substantive addiction, with only indirect links to physical health, the high number of Americans who exhibit some degree of social media addiction is concerning.

Inasmuch as social media presents us with a public health crisis, the American government should consider potential regulatory steps to address it.

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Close up of a Doctor making a vaccination in the shoulder of patient.

The CMS Vaccine Mandate: The Nationwide Injunction and What It Means

Kaitlynn Milvert Leave a comment

By Kaitlynn Milvert

On November 30, 2021, a federal district court issued a nationwide preliminary injunction to block the Centers for Medicare and Medicaid Services (CMS) vaccine requirements for health care workers.

This ruling comes mere days before the December 6 deadline for employees of CMS-funded facilities to receive their first dose of a COVID-19 vaccine, and it casts uncertainty over upcoming deadlines for vaccination compliance.

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